FDA Adverse Event
Malfunction
Summary report: N
WIRE COLLET
MDR report key: 2241579
·
Received September 2, 2011
Report
- Report Number
- 1811755-2011-03253
- Event Type
- Malfunction
- Date Received
- September 2, 2011
- Date of Event
- August 24, 2011
- Report Date
- August 24, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- GET
- PMA / PMN Number
- K943323
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RETURNED TO THE MFR FOR INVESTIGATION. BASED ON THE QUALITY INVESTIGATION, THERE WAS CORROSION BUILT UP INSIDE THE DEVICE. THIS CONDITION COULD CAUSE THE DEVICE TO STICK, AND NOT ALLOW THE COLLET TO RELEASE THE WIRE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE WIRE WAS STICKING IN THE DEVICE AFTER A PROCEDURE DURING CLEANING. THERE WAS NO PT INVOLVEMENT AND NO ALLEGATION OF ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | WIRE COLLET | GET | STRYKER INSTRUMENTS KALAMAZOO | 10322 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |